The Effect of Acupuncture as Adjunctive Therapy on Homeostasis Model Assessment-insulin Resistance and Health Related Quality of Life in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Fasting serum insulin
研究概览
简要总结
This study aims to determine the effect of acupuncture as an adjunctive therapy on homeostasis model assessment-insulin resistance (HOMA-IR) and health-related quality of life (HRQoL) in patients with type 2 diabetes mellitus.
详细描述
This is a randomised, double-blind, placebo controlled and parallel design trial. Participants will be randomized to either acupuncture (n=30) or placebo (n=30) using a 1:1 ratio. The permuted blocks with a block size of 2 will be used. Both groups will continue with their routine diabetes care. Primary outcome of HOMA-IR will be measured at the time of recruitment (baseline) and after completion of 10 sessions (week 7) of the treatment. Secondary outcome of HRQOL will be measured at the time of recruitment (baseline), after completion of 5 sessions (week 3/4) and 10 sessions (week 7) of the treatment while outcomes of body mass index and waist circumference are measured at the time of recruitment (baseline) and after completion of 10 sessions (week 7) of the treatment. Any adverse event will be recorded at every visit. The sequence generation and allocation will remain concealed from the patient and practitioner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 30 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fasting plasma glucose (FPG) ≥ 7.0 mmol/L [126 mg/dL] or HbA1c ≥ 6.5%.
- •Subjects have had type 2 diabetes mellitus for more than one year
- •Receive oral anti-diabetic agents on a stable dose over the previous 3 months.
排除标准
- •Under insulin therapy
- •With other acute or chronic health problems
- •Body mass index (BMI) ≥ 40.0 kg/m²
- •Needle phobia or allergy to adhesive plaster
- •Planning to move out from Malaysia within 4 months'
- •Being pregnant, planning for pregnancy or lactating women
结局指标
主要结局
Fasting serum insulin
时间窗: change from baseline fasting serum insulin at 7 weeks
Analyzed in μU/ml using heparin tube
Fasting plasma glucose
时间窗: change from baseline fasting plasma glucose at 7 weeks
Analyzed in mmol l-\^1 using sodium fluoride tube
Homeostasis model assessment- insulin resistance (HOMA-IR)
时间窗: change from baseline HOMA-IR at 7 weeks
Fasting serum insulin and fasting plasma glucose will be combined to report HOMA-IR in unit \[fasting serum insulin (μU/ml)×fasting plasma glucose (mmol l-1)/22.5\](Mathews et al., 1985).
次要结局
- Body mass index(change from baseline body mass index at 7 weeks)
- Health-related quality of life (HRQoL)(change from baseline HRQoL at 7 weeks)
- Weight(change from baseline weight at 7 weeks)
- Waist circumference(change from baseline waist circumference at 7 weeks)
- Incident of treatment adverse events in terms of intensity (grades 1 - 5)(7 weeks)
研究者
Cheok Yean Chin
Principle Investigator
Universiti Putra Malaysia